Sodium hyaluronate-based bioresorbable membrane (Seprafilm) reduced early postoperative intestinal obstruction after lower abdominal surgery for colorectal cancer: the preliminary report.
OBJECTIVE
This study is a prospective randomized clinical trial to evaluate the clinical safety and the effect of a sodium hyaluronate-based bioresorbable membrane (Seprafilm; Genzyme, Cambridge, MA, USA) for reducing adhesive intestinal obstruction after colorectal cancer surgery.


METHODS
Between November 2002 and December 2003, 504 patients underwent radical resection for sigmoid or rectal cancer. Among these patients, 427 patients were enrolled in this study. The patients were randomized into the Seprafilm group (N = 185) and the control group (N = 242). All the patients in the Seprafilm) group received one sheet of Seprafilm over the pelvic inlet where the peritoneum was denuded due to pelvic dissection. Intestinal obstruction was defined when there were symptoms of nausea, vomiting, and abdominal distension combined with an obstructive bowel pattern on the radiologic evaluation.


RESULTS
The median follow-up period was 25.0 months. There were no significant differences between the Seprafilm and the control groups for the clinicopathologic parameters. There were no differences in the incidence of complications between the two groups; however, the incidence of early postoperative intestinal obstruction was significantly less in the Seprafilm group than in the control group (2.7% vs 7.0%, respectively, p = 0.045). Five patients in the Seprafilm group experienced postoperative intestinal obstruction (2.7%) compared with 11 patients in the control group (4.6%) during the follow-up period; however, there was no statistical difference.


CONCLUSIONS
Seprafilm appears to be effective in preventing early postoperative intestinal obstruction and there was a trend for reduced intestinal obstruction after lower abdominal surgery for colorectal cancer.
Park
Chi-Min
CM
Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Ilwon-dong 50, Gangnam-gu, Seoul 135-710, South Korea.
Lee
Woo Yong
WY
Cho
Yong Beom
YB
Yun
Hae Ran
HR
Lee
Won-Suk
WS
Yun
Seong Hyeon
SH
Chun
Ho-Kyung
HK
D001672:Biocompatible Materials / Q000627:therapeutic use*; D016022:Case-Control Studies; D015179:Colorectal Neoplasms / Q000601:surgery*; D003710:Demography; D004751:Enteritis / Q000453:epidemiology; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000737:chemistry* / Q000627:therapeutic use; D015994:Incidence; D007415:Intestinal Obstruction / Q000188:drug therapy / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control*; D007723:Korea / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011182:Postoperative Care; D011183:Postoperative Complications / Q000188:drug therapy* / Q000209:etiology
D001672:Biocompatible Materials; C118198:Seprafilm; D006820:Hyaluronic Acid